• New Regulations Provide Guidance to Drug and Device Manufacturers for Establishing Effective Reporting Systems to Comply with Physician Payment Sunshine Act
  • February 1, 2012 | Author: Holly Johnsen Hoehner
  • Law Firm: Hiscock & Barclay, LLP - Syracuse Office
  • The Centers for Medicare and Medicaid Services (CMS) has issued proposed regulations that provide guidance to manufacturers on whether and how they are required to disclose payments or other transfers of value made to covered recipients, including physicians and teaching hospitals, in accordance with the Physician Payment Sunshine Act (the “Sunshine Act”) that Congress passed as part of the 2010 healthcare reform legislation. The proposed regulations contain many important changes and clarifications to the Sunshine Act, as summarized below, the most important of which is timing: Manufacturers are not required to collect payment data as of January 1, 2012. Instead, the data collection period is delayed until after implementation of the final regulations, expected later in 2012. CMS anticipates that the first report will be due as originally planned on March 31, 2013, disclosing payments made during the remainder of calendar year 2012 following implementation of the final regulations.